Pilot Study of an Extra Aortic Counterpulsation Device acutely attached to the ascending aorta in the open chest for patients with hypertensive heart failure

Not Applicable

Recruiting

• Conditions: Cardiovascular; Hypertensive heart failure; Hypertension; aortic stiffness; Cardiovascular - Hypertension; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12621000203853
• Lead Sponsor: BIOQ DEVICES PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-26
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion criteria will include
•Adults of 18 years or over
•Patient has read and signed the informed consent prior to study related procedures
•Willing and able to comply with all required follow-up evaluations and assessments
•Patients scheduled for Coronary Artery Bypass Grafting (CABG) will be assessed for:
1) hypertension and ejection fraction (EF) cut-offs defined below,
2) Presence of heart failure ( Class I to IV),
3) coronary artery disease,
4) aortic stiffness,
5) stroke risk,
6) valve dysfunction,
7) aortic calcification and atherosclerosis
8) ischemia/non-ischemia classification.

oGroup 1 will consist of up to 20 patients with hypertensive heart failure PLUS low ejection fraction (30% - 45% EF).
oGroup 2 will consist of up to 20 patients with hypertensive heart failure PLUS preserved ejection fraction (>50% EF).

Exclusion Criteria

Exclusion criteria will include:
•history of previous stroke,
•significant mitral and or aortic valve disease/dysfunction,
• ascending aortic disease calcification or atherosclerosis or aneurysm.
• intraoperative echo or epi-aortic ultrasound will be used during the surgical procedures to exclude or confirm presence of severe aortic disease before applying the device as a final precautionary measure prior to placement. Patients will be excluded at this point if they are confirmed in the exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified